Offer summary
Qualifications:
BS Degree with 12 years experience, Expertise in eCTD and document management, 8+ years of Regulatory Operations experience, Experience with IND/BLA/NDA/CTA submissions, Technical expertise in EDMS.Key responsabilities:
- Support global regulatory strategy implementation
- Manage submission planning and operations
- Interface with departments to meet timelines
- Prepare and track electronic submissions
- Lead documentation development for processes